BEUDAMED
    21 results · 25ms · Sources: EU EUDAMED, US FDA

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    Supercath 5

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SpheRx

    FDA UDI
    Nuvasive, Inc.·00887517427861·SpheRx II Base, Double Lead Screw Tray

    URI-CATH

    FDA UDI
    UTAH MEDICAL PRODUCTS, INC.·H67141900010·PEDIATRIC URINE METER for Urinary Drainage Coll...

    LOCATOR R-Tx

    FDA UDI
    Zest Anchors, LLC·00840481124532·LOCATOR R-Tx Attachment System, FairTwo S, Fair...

    PLDF Backpack Left

    FDA UDI
    Osteocentric Technologies, Inc.·00810074309332·PLDF Backpack Left

    Eargo SE

    FDA UDI
    Eargo, Inc.·00850010429755·Eargo Care - SE

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·therascreen PIK3CA RGQ PCR Kit

    Surgical tools for erythrocyte & marrow preparation kit

    FDA UDI
    Arteriocyte Medical Systems, Inc.·M89640K1000010·Sterile Disposable Kit containing single-patien...

    COLLEAGUE CX TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·December 2, 2010

    V-GRIP PLUS DETACHMENT CONTROLLER, MODEL VG503

    FDA 510(k)
    FDA Class 2 ·Neurology

    MOBIVISION

    FDA 510(k)
    FDA Class 2 ·Radiology

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·therascreen PIK3CA RGQ PCR Kit

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·therascreen® PIK3CA RGQ PCR Kit

    MAMBA? FLEX

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQY·September 11, 2025

    MICRO PLUG SET

    FDA Adverse Event
    Injury ·MERIT MEDICAL SYSTEMS, INC.·Product code KRD·April 16, 2026

    7700

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·June 18, 2013

    OXIMAX N-560 PULSE OXIMETER

    FDA Adverse Event
    Malfunction ·MEDIANA·Product code DQA·September 17, 2014

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO INC·Product code GJS·June 29, 2011

    MegaPower Electrosurgical Generator, Product code 1000, GTIN 10614559103715

    FDA Enforcement
    Class II ·Terminated·Megadyne Medical Products, Inc.·August 22, 2018

    OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX; d. OPTETRAK Logic CR Slope + Tibial Inserts, Product Line 02-012-48-XXXX; e. OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX; f. OPTETRAK Logic CRC Tibial Inserts, Product Line 02-012-51-XXXX; g. OPTETRAK Logic CC Tibial Inserts, Product Line 02-012-65-XXXX; Affected 510(k) numbers include: K033883, K132161, K093360, K110547, K111400, K121307, K123342, K150890. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021